Senior QA Specialist

MS0268 GE Healthcare Unidad Central de Radiofarmacia de Galicia, S.L.; La Coruña; Presencial; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

GE HealthCare is seeking a Sr. Quality Assurance Specialist to support Radiopharmacy operations in Galicia, Spain. The role involves maintaining the QMS, ensuring GMP compliance, and collaborating with the QA team and regulatory bodies to safeguard patient safety and product quality.

The successful candidate will bring a strong background in pharmaceutical QA, investigations, CAPA, change control, and risk management, with fluency in Spanish and English to liaise across local and global teams.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or another relevant scientific discipline.
• Minimum of 3 years of experience in a GMP-regulated pharmaceutical, radiopharmaceutical, biotechnology, or medical device environment.
• Experience working within Quality Assurance, Quality Systems, or a closely related function.
• Strong knowledge of EU GMP requirements and pharmaceutical quality systems.
• Experience with investigations, CAPA management, change control, and risk management processes.
• Professional proficiency in Spanish and English, both written and spoken.

Responsabilidades

• Maintain and continuously improve the QMS.
• Review and approve quality-related documentation.
• Support operational activities and drive compliance improvements.
• Collaborate with QA teams and regulatory bodies to ensure patient safety and product quality.

Conocimientos

GMP knowledge

QA systems

CAPA management

Radiopharmacy

Bilingual Spanish-English

Educación

Bachelor's degree in Pharmacy

Herramientas

eQMS

Descripción del empleo

Job Description Summary We are looking for a motivated and proactive Sr. Quality Assurance Specialist to join the Quality Assurance team supporting Radiopharmacy operations in Galicia, Spain. The successful candidate will work closely with the Responsible Pharmacist, the Technicians team in Galicia, the QA team that is mainly based in the Netherlands and other local and global functions to ensure compliance with applicable Good Manufacturing Practices (GMP), radiopharmacy regulations, and company quality standards. This role is critical in supporting the continuous improvement of the Quality Management System (QMS), maintaining inspection readiness, and ensuring that patient safety, product quality, and regulatory compliance remain central to daily operations. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

The Quality Assurance department is responsible for maintaining and continuously improving the QMS, reviewing and approving quality-related documentation, supporting operational activities, and driving compliance and quality improvement initiatives.

Required Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or another relevant scientific discipline.
• Minimum of 3 years of experience in a GMP-regulated pharmaceutical, radiopharmaceutical, biotechnology, or medical device environment.
• Experience working within Quality Assurance, Quality Systems, or a closely related function.
• Strong knowledge of EU GMP requirements and pharmaceutical quality systems.
• Experience with investigations, CAPA management, change control, and risk management processes.
• Professional proficiency in Spanish and English, both written and spoken.

Preferred Qualifications

• Experience in radiopharmaceutical manufacturing or hospital radiopharmacy operations.
• Experience supporting regulatory inspections and inspection readiness activities.
• Knowledge of validation and qualification activities.
• Experience using electronic quality management systems (eQMS).

Competencies

• Strong commitment to quality, patient safety, and regulatory compliance.
• Excellent analytical and problem-solving skills.
• Ability to challenge existing processes constructively and drive improvements.
• Detail-oriented, with a high level of accuracy and integrity.
• Strong organizational and project management skills.
• Effective communicator with the ability to collaborate across multiple departments.
• Proactive, self-motivated, and capable of working independently.
• Pragmatic and results-oriented, with a focus on sustainable solutions.
• Ability to manage multiple priorities in a fast-paced environment.
• Continuous improvement mindset with a passion for operational excellence.

What We Offer

• Opportunity to contribute to a radiopharmacy organization that directly supports patient care
• A collaborative and quality-focused work environment.
• Professional development and training opportunities.
• The chance to make a meaningful impact on quality, compliance, and operational excellence within a highly regulated healthcare setting.

Inclusion and Diversity: GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviours: We expect all employees to live and breathe our behaviours: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Total Rewards: Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

#LI-Hybrid #LI-AV1

Additional Information Relocation Assistance Provided: No At GE HealthCare, we see possibilities through innovation. We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.